An Intention-to-Treat Study of Salvage Chemotherapy Followed by Allogeneic Hematopoietic Stem Cell Transplant for the Treatment of High-Risk or Relapsed Hodgkin Lymphoma

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New York,
New York10065

Purpose:

RATIONALE: Giving chemotherapy before a donor stem cell transplant helps stop the growth of
cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem
cells. When the healthy stem cells from a donor are infused into the patient they may help
the patient's bone marrow make stem cells, red blood cells, white blood cells, and
platelets. Sometimes the transplanted cells from a donor can make an immune response against
the body's normal cells. Giving cyclosporine, mycophenolate mofetil, and methotrexate before
and after transplant may stop this from happening.
PURPOSE: This phase II trial is studying how well combination chemotherapy followed by donor
stem cell transplant works in treating patients with relapsed or high-risk primary
refractory Hodgkin lymphoma.

Study summary:

OUTLINE: Patients are stratified according to response to prior therapy and risk factors
(those with presence of all 3 risk factors and failed primary therapy or primary progressive
disease vs. patients who relapse more than 100 days after an autologous stem cell
transplant).
- Salvage chemotherapy (IGV or MOPP): Patients who have previously received
mechlorethamine hydrochloride receive IGV; patients who have previously received a
gemcitabine-based regimen receive MOPP.
- IGV (ifosfamide, gemcitabine hydrochloride, and vinorelbine ditartrate): Patients
receive IGV combination chemotherapy comprising ifosfamide IV on days 1-4,
gemcitabine hydrochloride IV on days 1 and 4, and vinorelbine ditartrate IV on day
1. Treatment repeats every 2-3 weeks for 2-3 courses in the absence of disease
progression or unacceptable toxicity.
- MOPP (mechlorethamine hydrochloride, vincristine, procarbazine hydrochloride, and
prednisone): Patients receive MOPP combination chemotherapy comprising
mechlorethamine hydrochloride IV on days 1 and 8, vincristine IV on days 1 and 8,
oral procarbazine hydrochloride on days 1-14, and oral prednisone on days 1-14.
Treatment repeats every 4 weeks for at least 2 courses in the absence of disease
progression or unacceptable toxicity.
Patients with no progression of disease after salvage chemotherapy (at allograft work-up)
proceed to allogeneic hematopoietic stem cell transplantation [AHSCT]* within 60 days after
completion of salvage chemotherapy.
NOTE: *Patients with a nodal mass > 5 cm that has not ben previously irradiated and in the
absence of extranodal disease may undergo involved-field radiotherapy twice daily for 2
weeks, prior to AHSCT.
- AHSCT with reduced-intensity or non-myeloablative conditioning: Patients achieving
partial response or stable disease after salvage therapy receive fludarabine phosphate
IV over 30 minutes on days -6 to -2; melphalan IV over 15 minutes on days -6 and -5;
and undergo AHSCT on day 0 (reduced-intensity conditioning). Patients achieving
complete response after salvage therapy receive fludarabine phosphate IV over 30
minutes on days -6 to -2; cyclophosphamide IV over 15 minutes on day -6; total-body
irradiation over 20-30 minutes on day -1; and undergo AHSCT on day 0 (non-myeloablative
conditioning).
- Graft-vs-host disease prophylaxis: Patients with related or unrelated donors receive
cyclosporine IV over 2-4 hours or orally on days -3 to 100 followed by a taper,
mycophenolate mofetil IV or orally on days -3 to 46 followed by a taper, and
methotrexate IV on days 1, 3, 6, and 11.
Patients who received umbilical cord blood receive cyclosporine and mycophenolate mofetil as
above (no methotrexate).
Follow-up period of 2 years post-transplant.